Here’s an interesting fight. On one side we have a group whose motto is “Don’t be evil.” The other side is very different: It’s the federal government.

In keeping with the times, in which presidents enforce whatever rules they feel like enforcing on any particular day, the Food and Drug Administration has added a new dimension to its mission. Now it’s the Food, Drug and Information Administration, because this week it ordered an info source to shut down.

Its opponent is a company called 23andMe, which for six years has been providing consumers with 98% reliable data about what’s in their genes. All of the sudden that must stop, said the FDA in a letter dated Nov. 22 that effectively ordered the company, which has one product, to shut down.

23andMe, backed in part by Google capital, is run by CEO Anne Wojcicki, who is currently separated from her husband, Google co-founder Sergey Brin. For the last several years, for 99 bucks, its customers have found that they swab some saliva, put it in a tube, send it to 23andMe’s labs and get back information on genetic traits. You may learn that you are predisposed to diabetes or cancer or merely that you lack the gene that causes “asparagus pee.” 23andMe isn’t, it seems obvious, a provider of drugs or medicines. It is simply an information service.

But the FDA has the power to regulate medical devices, which is the pretext it is using to stop 23andMe. Ordering it to stop selling its personal genome service, the FDA declared that the tube “is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or function of the body.’

It would seem that 23andMe could simply put the words, “not intended for us in the diagnosis, cure, mitigation, treatment or prevention of disease” on its website and satisfy the FDA, but we all know that the motto of today’s federales is “We make it up as we go along.” The FDA seems determined to conduct a lengthy war with 23andMe.

Stretching for examples of how 23andMe represents a public-health menace, the FDA came up with an absurdity. In its letter to Wojcicki, it cited the possibility that a gene linked to breast cancer, BRCA, could be revealed by 23andMe testing: “If the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening or other morbidity-inducing actions.”

That’s nuts. What woman would schedule a life-changing procedure such as chemotherapy or mastectomy based on a $99 mail-order test? What doctor would perform such a procedure without followup? 23andMe never claimed its results are 100% conclusive, nor does it advise clients to go get a scalpel and a mirror and start cutting. From the 23andMe.com site: “Learning your genetic risk for various diseases and conditions will allow you and your doctor to focus on the lifestyle changes and preventative steps that matter most for you . . . you will learn about variations in your DNA that can help your doctor determine if you need more or less of a medication compared to most people.” (Emphasis added).

Using the same reasoning, the FDA might as well shut down WebMd.com because people might type their symptoms into the site, and the response might affect whether or not they choose to go to a doctor. Any computer or iPhone thereby becomes a “medical device” that people can use for the “diagnosis, cure, mitigation, treatment or prevention of disease.”

Come to think of it, that thermometer you use to check your temperature is pretty dangerous too — it might give you either a false positive or a false negative — but why stop there? You exercise to mitigate or prevent disease, don’t you? Maybe the FDA should take your running shoes and your yoga pants away.

What’s different about 23andMe is that its saliva-testing tube is new, hence scary to the FDA, which is like a prim Victorian lady in a neck-high flannel dress holding one hand to her throat in generalized fear and shock while the other holds one of those ear trumpets she holds up while yelling, “Eh?” If FDA Lady doesn’t understand what you’re up to when you leave the house, you’re grounded indefinitely, made to sit in the corner on a stiff wing chair wishing the cat smell would go away. “What for? I’ll tell you what for, Missy! Because I said so!”

If only the reality were that congenial, though. In fact, little old FDA Lady has lots of huge friends, like NSA Creep upstairs reading your e-mail and IRS Thug getting out the brass knuckles because of your political affiliations.

What do all three of them have in common? They’ve had just about enough of your smart-mouth questions, sonny boy.

What do you think of the FDA's crackdown?

FOrget the idiocy of the US Government. Would YOU send your DNA to a stranger? Especially one with such strong ties to GOOGLE? ALl of sudden, many 'cold cases' will start being solved, albeit, with or without the TRUE CRIMINAL, but hey...they got millions of DNA samples to use, right? Any moron willing to give a private comany (not affiliated with THEIR DOCTOR) their DNA, deserve all the headaches that come with it.

Read two articles, taking on opposing sides of the issue.Should direct-to-consumer testing be
regulated as "the practice of medicine"?...Is the FDA's action a
cause for concern as it relates to our First Amendment rights?
http://lifesciencesnow.com/category/genetics/

"The FDA letter suggests that regulators have gone to great lengths to try and work with the company, citing months of meetings and dozens of letters between the two parties."

"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated" its technology, states the letter."

Why would 23and me be unwilling to disclose it's data supporting your stated 98% accuracy? Clearly Kyle is young, (as evidenced by his use of the archaic now resurgent use of the "all of THE sudden" idiom) but have you ever heard of laetrile? People who are ill will go to any length to obtain a diagnosis and treatment

when a cause is not readily identified. A test which is not validated by controlled studies can lead individuals to pursue "treatments" offered by quacks, who victimize the depressed, the despondent the sick (see quackwatch.com). Why would any company offering a legitimate service be unwilling to validate the accuracy of their testing???? Even facetiously comparing a "medical test"( implicit in 23and me's own advertising) to yoga, running shoes, a thermometer and Webmd isn't clever or snarky, it's simply nonsense.

This is actually sad. I better hurry and get my Scanadu Scout as that has multiple medical testing capabilities. I should probably get some serious hard drive space and start storing Physics and Chemistry knowledge as that will be next. This philosophy seems the opposite of what America should be. We should be putting more information and knowledge into peoples hands.

This dammed Obama administration is heading the American people into a civil war by imposing too many laws, the time will come when the American people will say ENOUGH and the revolt will begin, I just hope I'm not around to see it as there will be no victors only dead everywhere. following in the footsteps from former powers in the ancient as well as the modern one.

You've got to understand that he feels the absolute right to issue executive orders that are not laws passed by congress, he hired 'czars' who publish some garbage that passes as a "law". Citizens need to understand that the totalitarian left is thrilled we are not screaming, not suing, not making our Senators fight this illegal power grab. In a few years children will talk about the time they 'used to be free' to buy something...

Vote, vote, vote. Make sure you find the candidates opposed to totalitarian rule by decree, make sure you know how your local politicians feel about being controlled by the UN (where Barry is heading next) and vote them out of office.

As is ALWAYS the case when dealing with jack-booted Liberals, Leftists, Socialists, Statists, Communists, and the current administration - IT'S ABOUT CONTROL!

Only THEY know what's best for the rest of us. Only THEY know how to spend OUR money. Only THEY know what we can eat, drink, inhale, etc. Only THEY know what we should read, see, say, or think. Only THEIR pseudo-science is valid (see the global warming/climate change hoax, the anti-fracking lobby, etc.) Only THEY know when you're sick, or when you can see a doctor, or even IF you have a doctor still in practice.

These are the same people who claimed there are anywhere between 10 and 35 million people without health coverage, sought to address this problem by blowing-up the entire healthcare system, and now face the very real likelihood of having 100+ MILLION without any coverage!

THIS is what you voted for, America - twice! And you STILL haven't gotten the message that socialism has been and will always be an abject, utter FAILURE every time it is tried. The Founding Fathers are looking down at us and wondering how and where did the country they created devolve into a nation of easily-duped morons who continually vote for FAILURE.

Why would any sane person trust the likes of Barack Hussein Rouhani Obama or any of his appointed minions? If you've partaken of his brand of Kool-Aid and actually believe that his appointees are looking out for the citizens vs the exercise of absolute oppressive authority over every facet of your life, then you have liked the experience of being Obamanized.

@Anon Why do you think the leftists are ALL about gun control? They'll tell you it's for everyone's "safety" and how they always "mean well" and have the "greater good's" best interests in mind when they demand we hand over our guns to THEM.

I don't own a gun, never had a need or use for one - I've never even touched one in my entire life. But their incessant demands for greater and greater control over every minute aspect of our lives is giving me pause to reconsider.

All I know is this: Far too many GOOD Americans fought and died for the freedoms we once enjoyed and which are now under constant attack. I guarantee you the America we all grew-up with and learned about in school will cease to exist the minute we voluntarily hand over our guns to these lying, thieving, conniving, socialist scum.

@Brewski1957 THe founders stopped checking up on the United States, back in the early 1900s when we let the bankers take over (going directly OPPOSITE of the advice of Jefferson, Franklin and others). I love the fact that you act as if the elite/wealthy, in control of the United States, had nothing to do with appointing yet another hereditary President. It seems to matter more to you, that a democrap rather tan a repukelican, a liberal rather than a conservative, or a socialist rather than a capitalist, is the one doing the robbing, fraud and criminality. Do you think the Founders would have cared if it were Tory or Whig, who wanted to legislate everyday life? Nope. Tyrrany is tyrrany, regardless of the poster-boy.